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Lung Cancer Screening Decisions (VA-LCSDecTool)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02899754
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

Veterans have a high risk of developing lung in comparison to general populations due to their older age and smoking history. Recent evidence indicates that lung cancer screening with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the rates of false positive findings are high, requiring further testing and evaluation. Preliminary studies report that while some Veterans are enthusiastic about screening, others are highly reluctant. Patient preferences should be considered as part of an informed decision making process for this emerging paradigm of lung cancer control. Effective methods for preference assessment among Veterans have not yet been developed, evaluated, and integrated into clinical practice. The specific aims of this study are to 1) elicit patient and provider stakeholder input to inform the development of a lung cancer screening decision tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool compared to usual care on the decision process, clinical outcomes, and quality of life.

(5/8/18)-This project involves the recruitment of both Veterans as well as health care providers/leaders. Patient recruitment efforts at both sites will target male and female patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer screening. Our recruitment goals for patients are 40% African American, 5% Hispanic patients, and 10% women.

(10/25/2018) Patient recruitment efforts at both sites will target male and female To Date, 32 Veterans have signed the consent form and completed their portion of the trial (16 at CMCVAMC and 16 at West Haven, CT). To Date, 61 Providers have completed their portion of the trial (18 at CMCVAMC and 43 at West Haven, CT). Enrollment for Phase 1 is complete. Enrollment for Phase 2 will begin in June, 2018.patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer screening. Our recruitment goals for patients are 40% African American, 5% Hispanic patients, and 10% women. To Date, 9 Veterans have signed the consent form and completed their portion of the trial (9 at CMCVAMC and 0 at West Haven, CT). Enrollment for Phase 2 is ongoing with the intent to complete By November 30, 2018.

(01/15/2019) Phase 2 patient recruitment is complete. 18 Veterans have signed the consent form and completed their portion of the trial (12 at CMCVAMC and 6 at West Haven, CT). 14 Providers have completed their portion of the trial (8 at CMCVAMC and 6 at West Haven, CT). Enrollment for Phase 3 will begin in February, 2019.

To Date (7/1/2019) Enrollment for Phase 3 is ongoing with the intent to complete by February 28, 2020. To Date, 18 Veterans have signed the consent form and completed their baseline portion of the trial (18 at CMCVAMC and 0 at West Haven, CT).

To Date (12/3/2019) Enrollment for Phase 3 is ongoing with the intent to complete by February 28, 2021. A 1-year study extension has been submitted and awaiting approval. To Date, 70 Veterans have signed the consent form and completed their baseline portion of the trial (65 at CMCVAMC and 5 at West Haven, CT).

To Date (9/9/2020) Enrollment for Phase 3 has just resumed after being placed on administrative hold since March 2020 due to Covid-19. Secondary Site in West Haven, CT has been replaced by Milwaukee, WI. To Date, 90 Veterans have signed the consent form and completed their baseline portion of the trial (83 at CMCVAMC, 5 at West Haven, CT and 2 at Milwaukee, WI).


Condition or disease Intervention/treatment Phase
Lung Cancer Screening Behavioral: Lung Cancer Screening Decision Tool Behavioral: Control Intervention Not Applicable

Detailed Description:
Lung cancer is the leading cause of cancer deaths in the United States. Recent clinical trials provide evidence that screening with low dose CT scans will decrease lung cancer and all cause mortality among older heavy smokers. Clinical guidelines have been issued with the USPSTF recommending annual screening from age 55 to 80 for those with 30 pack years or more of smoking or who quit less than 15 years ago. Evidence clearly delineates both the benefits (mortality reduction) and harms (false positives, follow-up testing, risk of invasive testing, and risk of overdiagnosis) of lung cancer screening. Preliminary data from an HSR&D pilot grant finds that some Veterans are highly reluctant to enter the care pathway associated with lung cancer screening due to its potential harms. Additional preliminary data using Best Worst Scaling in older smokers demonstrate groups of patients who place greater importance on harms than benefit when considering lung cancer screening. Preference assessment methods can help Veterans to weigh benefits and harms, consider the clinical pathway they are entering, anticipate future health states, and communicate these values to their health care providers. Although basic educational tools to inform lung cancer decision-making have been developed, there is a lack of validated preference assessment tools that can be integrated into the clinical setting. Building upon preference assessment methods developed and validated in an HSR&D pilot grant (PI-Schapira) and using a trans-disciplinary approach, this team is positioned to advance the science and practice of decision support for lung cancer screening in the Veteran population. The objectives of this study are to 1) elicit patient and provider stakeholder input to inform the development of a lung cancer screening decision tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool compared to usual care on the decision process, clinical outcomes, and quality of life. The study will be conducted in 3 phases. In phase 1, mixed methods will be used to assess usability of preference assessment methods and perceived usefulness of a web based lung cancer screening decision support tool among patient and provider stakeholders. In phase 2, an interactive web based decision support program will be developed that incorporates preference assessment methods. In phase 3, a pilot RCT will be conduced to evaluate the efficacy of the web based decision support program. Outcomes evaluated will include decision quality as indicated by knowledge, decisional conflict, and decision regret; screening behavior, clinical outcomes as indicated by anxiety, and quality of life. The study will be conducted across two VA sites; West Haven-VA in Connecticut and Corporal Michael J. Crescenz VA in Philadelphia, Pennsylvania. Results of this study will provide tools that can be used to integrate lung cancer screening into clinical practice at VA Medical Centers in a patient centered approach. Lung cancer screening is fundamentally different from existing screening paradigms in several respects; eligibility is defined by a behavior (smoking), a high rate of false positive findings is expected, and the target population is older with higher comorbidity than the target population for cervical, breast, or colorectal screening. Given these unique aspects of lung cancer screening, there is a critical need to develop and test tools for preference assessment and informed decision making that are applicable for the VA setting. The current proposal provides a mechanism to accomplish these goals. The Principal Investigator is working closely with the US Department of Veterans Affairs National Center for Health Promotion and Disease Prevention to integrate the tools and paradigm developed to primary care in the VA Medical Care System. The work builds directly upon a recently completed HSR&D pilot support in the area of lung cancer and shared decision making.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Incorporating Veterans Preferences Into Lung Cancer Screening Decisions
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Behavioral: Lung Cancer Screening Decision Tool
This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
Other Name: LCSDecTool

Active Comparator: Control Group
Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer.
Behavioral: Control Intervention
This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
Other Name: Control




Primary Outcome Measures :
  1. Decision Regret [ Time Frame: 1 month following intervention ]
    Decision regret as measured by a 5-item Decision Regret scale that is patient reported.

  2. Decisional Conflict [ Time Frame: 1 month following the intervention ]
    Decisional conflict as measured by a 16 item Decisional Conflict scale that is patient reported


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: 1 month following intervention ]
    State anxiety as measured by the State Trait Anxiety Index

  2. Lung cancer worry [ Time Frame: 1 month after the intervention ]
    Lung cancer worry as measured by a 7 item scale that is patient reported

  3. Lung cancer screening uptake [ Time Frame: 6 months after the intervention ]
    Assessed by chart review



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 55-80 years
  • Enrolled in a Patient Aligned Care Team at a participating site
  • 30 or more pack years of smoking
  • Active smoker or quit smoking within 15 years

Exclusion Criteria:

  • Cognitive impairment as determined by clinical history
  • Previous diagnosis of cancer with the exception of non-melanoma skin cancer and localized prostate cancer that is 1-year post-diagnosis
  • Life expectancy of less than 2 years as indicated by chart review and conformation with PCPC
  • Inability to speak English
  • Active surveillance of Lung Nodule,
  • Enrolled in CMCVAMC Lung Cancer Screening Program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899754


Contacts
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Contact: Marilyn M Schapira, MD MPH (215) 823-5800 Marilyn.Schapira@va.gov
Contact: Jason Prigge, BS MS (215) 823-5800 ext 3883 Jason.Prigge@va.gov

Locations
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United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Active, not recruiting
West Haven, Connecticut, United States, 06516
United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kimberly M Brown, PhD    215-823-5800 ext 6248    Kimberly.Brown6@va.gov   
Principal Investigator: Marilyn M. Schapira, MD MPH         
United States, Wisconsin
Clement J. Zablocki VA Medical Center, Milwaukee, WI Recruiting
Milwaukee, Wisconsin, United States, 53295-1000
Contact: Jeffrey Whittle, MD    414-384-2000 ext 46444    Jeffrey.Whittle@va.gov   
Contact: Julie Rieder    414-384-2000 ext 46628    Julie.Rieder@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Marilyn M. Schapira, MD MPH Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Principal Investigator: Jeffrey C Whittle, MD MPH Clement J. Zablocki VA Medical Center, Milwaukee, WI
Additional Information:
Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02899754    
Other Study ID Numbers: IIR 15-143
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) that indicates adherence to any applicable Informed Consent provisions, appropriately limits use of the dataset and prohibits the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

A De-identified, Anonymized Dataset will be created and shared.

A limited coded dataset will be made available on our CMCVAMC research website that is publically available.

The dataset will be housed on a server, administered by CHERP behind the VA firewall, access being granted only to those who apply directly to the principal investigator , provide the necessary assurances that they will not re-identify the data, and submit to a clearance by the CMCVAMC Privacy Officer


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
lung cancer
decision support
implementation
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases